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For Regulatory or Inspection Questions email: ohcq.labs@maryland.govEmail is the fastest and most efficient way to obtain support.Typical response time for questions received during business hours is 2 hours.Local Phone:410-402-8025Toll Free Phone:877-402-8202Fax: 410-402-8213

If lines are busy please use email support for the fastest response.

The Clinical Laboratories Unit is responsible for State licensure of all clinical laboratories that perform tests on specimens obtained from Maryland citizens and for federal certification of all clinical laboratories located in Maryland. The unit also serves as the agent for federal certification in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program, which is required for all clinical laboratory testing sites including those seeking Medicare reimbursement. The State only licensing programs include those for tissue banks, cholesterol testing sites, and health awareness testing sites.

Health Awareness TestingIn Maryland, Health Awareness Testing means a test approved by the Secretary to be performed at a temporary laboratory; such as a health fair in a shopping mall. Health Awareness testing is limited to: Tests that are performed soley for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions; and that are performed on a CLIA waived testing device; and measure glucose, lipids, or other clinical values which the Secretary has concluded are in the interest of public health to be measured at a health awareness event. If you plan to perform Health Awareness Testing in Maryland please review the regulations set forth in COMAR 10.10.06.12, 10.10.06.13 and 10.10.06.15. You must also inform the OHCQ by phone or in writing of the date, time, location, and on-site supervisor's name for a testing event at least 14 days before the event is to take place, per COMAR 10.10.06.14. For questions regarding Health Awareness Testing the contact person may be reached by email at gail.mcgucken@maryland.gov or by telephone at 410-402-8023. COMAR regulation can be searched here:http://www.dsd.state.md.us/comar/searchall.aspx

Explore comprehensive information on our Laboratories program in the sections below: